Sr IT Compliance Analyst

About the Department At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products. At API, you'll join a global network of manufacturing professionals who are passionate about what they do. What we offer you: Leading pay and annual performance bonus for all positionsAll employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & Disability InsuranceEmployee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position Provide subject matter expertise in IT compliance, process improvement and IT compliance service delivery management across the site. Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders. Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization's goals of improving the lives of people with chronic diseases. Relationships Reports to Director / Associate Director. Essential Functions Develop and maintain validation and qualification documentationConduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategiesProvide guidance and support to project teams on validation and qualification requirementsContinuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standardsFacilitate the seamless transition and handover of projects to service operations with key stakeholdersMaintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirementsParticipate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycleCollaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycleEnsure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standardsProvide leadership and expertise in IT compliance, process improvement, and project coordinationCoach and mentor personnel, and provide guidance as neededParticipate in process group meetings and contribute to process group activitiesFollow all safety & environmental requirements in the performance of dutiesOther duties as assigned Physical Requirements May move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12 hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. % can change on a case-by-case basis based on the role. Qualifications Bachelor's Degree in IT, Engineering, Science, or relevant field of study from an accredited university requiredMaster's degree in IT, Engineering, Science, or relevant field of study from an accredited university preferredMinimum of seven (7) years of experience in IT compliance required, preferably within the pharmaceutical industryMinimum of five (5) years of experience on Validation and Testing of IT Solutions required, preferably within the pharmaceutical industryCertified Information Systems Auditor (CISA) is preferredLean Six Sigma Green Belt or Black Belt is preferredExperience as SME participating in Audits and Inspections preferredExperience on GxP, change management and deviation handling preferredExperience with Incident, Problem, and Change Management in IT preferredExcellent writing and communication skills, in English requiredExcellent customer service skills and ability to collaborate effectively in a team environment requiredExcellent problem solving, negotiation, conflict management, and interpersonal skills requiredExcellent planning, organizing, decision making and deal with complexity and ambiguity requiredStrong computer skills and MS Office Expert required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at .... This contact is for accommodation requests only and cannot be used to inquire about the status of applications.